# LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (K261370): 510(k) cleared for Guangdong Newdermo Biotech Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 30/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261370 |
| Device | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) |
| Applicant | Guangdong Newdermo Biotech Co., Ltd. |
| Specialty / panel | Neurology |
| Product code | NFO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-27 |
| Decision date | 2026-09-16 |
| Review time (days) | 142 |
| Third-party review | No |
| Applicant location | Guangzhou, CN |

## Why this score
- Fast 142-day review: this device is a strong predicate for similar products.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261370). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.